Sample dossiers

What the RAPL dossier engine produces from a single study definition: a simulated clinical trial, its CDISC datasets and statistical analysis, and a full ICH CTD dossier (Modules 1–5 plus trial-master-file, programme and quality documents). Every number the engine's reconciliation gate checks is listed with the documents that state it.

GLPI-103

GLP-1 / Apelin (APJ) receptor dual agonist

Indication: Type 2 Diabetes Mellitus
Documents: 100
Numbers traced: 23

TILA-278

anti-TL1A / IL-22 agonist bispecific antibody

Indication: Ulcerative Colitis (moderate-to-severe)
Documents: 98
Numbers traced: 35

OBX-319

anti-CD19 x anti-CD20 B-cell-depleting bispecific antibody

Indication: Systemic Lupus Erythematosus (moderate-to-severe active)
Documents: 98
Numbers traced: 35

Sources: the engine is RAPL/dossier; the outputs shown here live in the separate GLP1a_mock sample repository.